Preeclampsia and Circulating Biomarkers

January 5, 2015 updated by: University of Aarhus

In order to assess circulating biomarkers of cardiovascular risk, we will conduct a 10-year follow-up study comparing 32 exposed (women with a history of pregnancy complicated by preeclampsia) and 32 unexposed (women with a history of uncomplicated pregnancy).

Participants will be recruited from a well-characterised cohort, previously assembled during their pregnancies, at the Department of Obstetrics at Randers Regional Hospital in 2001-2004.

Blood and urine samples, collected during their pregnancies, are stored in a biobank, thus rendering the possibility of longitudinal assessment.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Randers NØ
      • Randers, Randers NØ, Denmark, 8930
        • Recruiting
        • Randers Regional Hospital
        • Contact:
          • Martin Christensen, MD
          • Phone Number: 004578422354
          • Email: marticis@rm.dk
        • Principal Investigator:
          • Martin Christensen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Participants will be recruited from a well-characterised cohort, previously assembled at the Department of Obstetrics at Randers Regional Hospital in 2001-2005.

Description

Inclusion Criteria:

  • Participation in previous study 2001-2005.

Exclusion Criteria:

  • Current pregnancy or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Exposed
Women with a history of preeclampsia 10 years ago
Unexposed
Women with a history of uncomplicated pregnancy 10 years ago

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Circulating biomarkers of cardiovascular disease 10 years postpartum.
Time Frame: 10 years postpartum
10 years postpartum

Secondary Outcome Measures

Outcome Measure
Time Frame
Markers of arteriosclerosis and atherosclerosis
Time Frame: 10 years postpartum
10 years postpartum
Circulating biomarkers of cardiovascular disease at baseline pregnancy.
Time Frame: During pregnancy
During pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Central Denmark Region
Karen Elise Jensen Foundation
Randers Regional Hospital

Investigators

  • Principal Investigator: Martin Christensen, MD, Clinical Research Unit, Randers Regional Hospital
  • Study Director: Camilla S Kronborg, MD, PhD, Department of Oncology, Aarhus University Hospital
  • Study Chair: Ulla B Knudsen, Professor, Department of Obstetrics and Gynaecology, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 1, 2014

First Submitted That Met QC Criteria

May 8, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Estimate)

January 6, 2015

Last Update Submitted That Met QC Criteria

January 5, 2015

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98372017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postpartum CVD Risk in Women With Previous Preeclampsia.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe